CINFADOL SPRAY 39.2 mg/mL CUTANEOUS SOLUTION FOR SPRAY

Introduction

Package Leaflet: Information for the Patient

Cinfadol SPRAY 39.2 mg/ml Cutaneous Spray Solution

Diclofenac Sodium

Read this package leaflet carefully before starting to use this medicine, as it contains important information for you:

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Package Leaflet Contents:

1. What Cinfadol SPRAY is and what it is used for.
2. What you need to know before starting to use Cinfadol SPRAY.
3. How to use Cinfadol SPRAY.
4. Possible side effects.
5. Storage of Cinfadol SPRAY.
6. Package Contents and Additional Information

1. What Cinfadol SPRAY is and what it is used for

Diclofenac sodium, the active ingredient of this medicine, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and acts as a local analgesic and anti-inflammatory.

This medicine is used in adults and adolescents over 14 years of age for the symptomatic relief of mild to moderate pain and inflammation of small and medium joints and surrounding structures after an acute injury.

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before starting to use Cinfadol SPRAY

Do not use Cinfadol SPRAY:

• If you are allergic (hypersensitive) to diclofenac sodium, peanut, soy, or any of the other components of this medicine (listed in section 6).
• If you have ever suffered an allergic reaction associated with difficulty breathing, skin rash, and runny nose (rhinorrhea) to any other medicine used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (also used to prevent blood clotting). If you are unsure, consult your doctor or pharmacist.
• If the patient is a child or adolescent under 14 years of age.
• On wounds, inflamed or infected skin, eczematous lesions, or burns, or mucous membranes.
• During the third trimester of pregnancy – see the section on pregnancy and lactation.
• On the chest area in breastfeeding women.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medicine.

• If you have or have had stomach ulcers, liver or kidney problems, bleeding tendency, or inflammatory bowel disease.
• If you have had bronchial asthma or allergies.
• Do not apply it to areas of the skin where there are open cuts or wounds, or on mucous membranes, or over eczema or areas of the skin with a rash.
• Stop using the medicine if a skin rash appears after application.
• Avoid using it on large areas, unless advised by a doctor. Use it exclusively on the affected area.
• Avoid eye contact. If this happens, rinse your eyes with clean water and consult your doctor or pharmacist if you feel any discomfort afterwards.
• Do not cover the treated area with occlusive dressings (waterproof or non-breathable) or band-aids.
• Do not use more medicine than indicated, or for a longer period than indicated, unless advised by your doctor.
• Do not apply other medicines simultaneously to the same area where this medicine has been applied.
• Do not ingest this medicine or use it in the mouth. This medicine is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
• The treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet radiation lamps (UVA rays).

The possible appearance of systemic side effects related to the use of this medicine cannot be excluded if it is used on large skin areas for a long period of time.

Side effects can be reduced by using the minimum effective dose for the shortest possible time.

Children and Adolescents

Do not use this medicine in children and adolescents under 14 years of age.

Other Medicines and Cinfadol SPRAY

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those purchased without a prescription.

Tell your doctor before using this medicine:

• If you are taking tablets, capsules, or using suppositories for pain, including any medicine that contains diclofenac sodium, acetylsalicylic acid (aspirin), or any other anti-inflammatory medicine, such as ibuprofen.

The use of another NSAID (e.g., acetylsalicylic acid or ibuprofen) along with this medicine may increase the risk of side effects.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not use this medicine if you are in the last 3 months of pregnancy. Do not use this medicine during the first 6 months of pregnancy, unless it is strictly necessary and recommended by your doctor. If you need treatment during this period, you should take the minimum possible dose for the shortest possible time.

Oral formulations (e.g., tablets) of diclofenac may cause adverse reactions to the fetus. It is unknown if this same risk applies to diclofenac when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

During breastfeeding, do not use this medicine, unless your doctor has indicated it.

In no case should it be applied directly to the chest area or to other large areas of the skin or for a prolonged period.

Driving and Using Machines

The cutaneous use of this medicine has no effect on the ability to drive or use machinery.

Cinfadol SPRAY contains propylene glycol (E-1520), soybean lecithin, and peppermint oil:

• It may cause skin irritation because it contains propylene glycol (E-1520).
• It contains soybean lecithin. Do not use this medicine if you are allergic to peanuts or soy.

It contains peppermint oil, which may cause allergic reactions.

3. How to Use Cinfadol SPRAY

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist again.

The recommended dose is:

Adults and Adolescents over 14 years of age:Apply 4-5 sprays of the spray 3 times a day at regular intervals, on the hand or directly on the painful or inflamed area, always with a gentle massage to facilitate penetration into the skin. The amount of this medicine will vary depending on the size of the affected area. Never exceed a maximum dose of 5 sprays at a time or 15 sprays per day on the affected area.

Treatment can be interrupted when symptoms (pain and swelling) have subsided.

Treatment should not continue for more than 7 days without medical review.

Consult your doctor if it worsens or does not improve after 3 days of treatment.

Use in Children and Adolescents:

Do not use in children or adolescents under 14 years of age.

Mode of Use:

This medicine is a solution for cutaneous use (external use). It should not be administered by any other route under any circumstances.

Follow the instructions carefully:

• Remove the transparent protective cap from the pump.
• Before the first use, it is necessary to press the pump four times to activate it, discarding the contents of the same. Failure to perform this priming process may result in the application of a lower dose when used for the first time.
• Administer the recommended dose of medicine with the dispenser container in a vertical position on the hand or on the painful or inflamed area.
• Spread the solution on the skin over the area where there is pain and inflammation, with a gentle massage. Afterwards, wash your hands unless it is the area being treated.

If you use more Cinfadol SPRAY than you should

If you apply more medicine than indicated, remove the excess with a swab.

If you accidentally ingest this medicine or if you have used it on a large area of skin and for a long period of time, systemic side effects similar to those produced by diclofenac when taken orally (e.g., tablets) may occur.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (91 562 04 20), indicating the medicine and the amount ingested.

If you forget to use Cinfadol SPRAY

If you forget to apply this medicine when it was due, apply the solution as soon as possible and continue the treatment as you were doing. Do not use a double dose to make up for a forgotten dose.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Interrupt treatment with this medicine if a skin rash appears. After topical application (skin application) of preparations containing diclofenac, the appearance of reactions at the application site, such as rash, itching, redness, burning sensation, or skin peeling, has been frequently observed.

Some rare and very rare side effects can be serious:

If you experience any of the following signs of allergy, interrupt the use of this medicine and consult your doctor or pharmacist immediately.

• Rare (may affect up to 1 in 1,000 people): Skin rash with blisters; urticaria (red, raised, and often itchy hives).
• Very rare (may affect up to 1 in 10,000 people): Difficulty breathing or feeling of pressure in the chest (asthma); swelling in the face, lips, tongue, or throat.

Other side effects may occur, but they are usually mild and transient. If you notice any of them, consult your doctor or pharmacist as soon as possible.

• Common (may affect up to 1 in 10 people): Rash, itching, redness, or burning sensation on the skin after using the medicine.
• Very rare (may affect up to 1 in 10,000 people): The skin may be more sensitive to the sun (photosensitivity). The signs are: sunburn with itching, swelling, and blisters. Pustular rash.
• Frequency not known (cannot be estimated from available data): Burning sensation at the application site, dry skin.

If diclofenac is applied topically to a very large skin area and for a long period of time, systemic side effects, such as stomach pain and gastrointestinal disorders, stomach acid, liver or kidney problems, and hypersensitivity reactions, may occur.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinfadol SPRAY

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not use this medicine after the expiration date that appears on the container, after "EXP". The expiration date is the last day of the month indicated.

Once opened, discard the bottle with the remaining solution after 6 months.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Cinfadol SPRAY Composition:

• The active ingredient is diclofenac sodium. Each ml of cutaneous spray solution (equivalent to 5 sprays) contains 39.2 mg of diclofenac sodium. Each spray (0.2 ml of solution) releases 7.84 mg of diclofenac sodium.
• The other components (excipients) are: Isopropyl alcohol, Phospholipon 90G (contains soybean lecithin-derived phosphatidylcholine, tocopherol as an antioxidant, lysophosphatidylcholine, and non-polar lipids), ethanol, disodium phosphate anhydrous, sodium dihydrogen phosphate dihydrate, disodium edetate, propylene glycol (E-1520), ascorbyl palmitate, peppermint oil, 10% hydrochloric acid, 10% sodium hydroxide (E-524), and purified water.

Appearance of Cinfadol SPRAY and Package Contents:

Light yellowish transparent solution with a peppermint odor that acquires a gel-like consistency after application.

Ambber glass bottle with 30 ml of solution (25 g) provided with a pump and polyethylene immersion tube.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

FARMALIDER, S.A.

Aragoneses, 2

28108 Madrid

Spain

or

MEDINFAR MANUFACTURING S.A.

Parque Industrial Armando Martins Tavares,

Rua Outeiro Da Armada No 5,

Condeixa-a-Nova, 3150-194, Portugal

Date of the Last Revision of this Package Leaflet:September 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).